lv thrombus after acute ami: a randomized controlled trial

Conditions: Ventricular Thrombosis Mural Following Myocardial Infarction

Summary: left ventricular (lv) thrombus formation is witnessed in at least 10% of patients with st segment elevation myocardial infarction (stemi). it is a feared complication since it might increase the risk of thrombo-embolic events, including stroke. guidelines recommend vitamin k antagonist treatment in these patients. however patients with stemi nowadays undergo primary percutaneous coronary intervention (pci) with coronary stent placement and consequently require dual anti-platelet therapy (ascal and p2y12 inhibitors) to prevent stent thrombosis. consequently, stemi patients with lv thrombus are currently treated with triple antithrombotic therapy (aspirin, p2y12 inhibitors, e.g. clopidogrel (75 mg/d) and vitamin k antagonist). patients treated with triple antithrombotic therapy are subject to a strongly increased bleeding risk with a yearly incidence of 3.7% for dual anti-platelet therapy as compared to 12% for triple antithrombotic therapy. about 10% of these bleedings are cerebral. the mortality of such haemorrhagic strokes is 25%. a recent retrospective analysis did not show any beneficial effects of addition of vitamin k antagonist to dual anti-platelet therapy to prevent stroke. if vitamin k antagonist-therapy could be omitted, morbidity and mortality due to post-pci bleedings will decrease. therefore, a randomized trial is warranted to address this issue. design: a multicenter, prospective, randomized, two non-inferiority trial. the objective of the study is to determine in a randomized fashion the risks and benefits of the addition of vitamin k antagonists to dual anti-platelet therapy or dual anti-platelet therapy in patients with pci-treated stemi and lv thrombus formation on baseline echocardiography or baseline magnetic resonance imaging (mri).

design: a multicenter, prospective, randomized, non-inferiority trial with blinded evaluation of endpoints objective: the objective of this study is to determine in a randomized fashion the risks as well as the benefits of the addition of vitamin k antagonists to dual anti-platelet therapy in patients with pci-treated stemi and lv thrombus formation patients: patients with acute myocardial infarction treated with primary pci and lv thrombus on baseline echocardiography or baseline magnetic resonance imaging. (mri) methods: after written informed consent has been obtained, echocardiography and mri are performed between 7-12 days after pci. when lv thrombus is present on baseline mri, patients are randomized to 1. triple antithrombotic therapy (aspirin (100 mg/d), thienopyridine class antiplatelet agent,) and vitamin k antagonist (goal inr is 2.0 to 3.0)) 2. dual anti-platelet therapy (aspirin (100mg/d) and thienopyridine class antiplatelet agent, e.g. clopidogrel (75 mg/d). primary endpoint: primary outcome is defined as the proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by mri. secondary endpoints: the secondary endpoints as assessed at 6 and 12 months are: * the composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism * presence of new cerebral mirco-bleeds * the occurrence of major and minor bleeding * neurological status and quality of life.

Eligibility criteria:
inclusion criteria: * suspected left ventricular thrombus on echocardiography or routine magnetic resonance imaging * ongoing treatment with dual antiplatelet therapy according to esc/acc-aha guidelines at the time of randomization. exclusion criteria: * younger than 18 * clinically or hemodynamically unstable * treatment with vitamin k antagonist prior to pci or other expected indication for vitamin k antagonist treatment (e.g. atrium fibrillation) within the next 6 months * previous stroke or transient ischemic attack * scheduled for major surgery (including coronary artery bypass grafting) during the course of the study * active bleeding or high risk for bleeding contraindicating treatment with vitamin k antagonists * contra-indication for vitamin k antagonist treatment * chronic treatment with nsaids or cox-2 inhibitors for more than 4 days per week anticipated to continue during the study * congenital cardiac disease * presence of supraventricular or ventricular arrhythmias * expected candidate for icd implantation with the next 6 months * severe renal impairment (estimated crcl calculated by cockcroft-gault equation 5 30ml/min) * known or symptomatic brain disease (such as brain tumor) * women who are pregnant. * any contraindication for contrast-enhanced magnetic resonance imaging (such as pacemaker, cerebrovascular clips, known contrast allergy, claustrophobia) * follow-up impossible (for example no fixed abode)

Keywords: left ventricular thrombus acute myocardial infarction anticoagulation